Dr Vinciane Poulet

Department of Maxillofacial Surgery

Pierre-Paul Riquet Hospital
Toulouse University Hospital
Place Baylac, 31059 Toulouse
France

d
Email: [email protected]

Dear Editor,

we
Please find our original article for consideration for publication in the Journal of Stomatology,
Oral and Maxillofacial Surgery. Our manuscript is entitled:

The use of nasal retainers in primary management of cleft lip: current practices in France

vie
Hightlights

 Nasal retainers are widely used after primary cheilorhinoplasty in France

 Different centers use different protocols for postoperative conformation
 Retainers are generally prescribed for 3–4 months after surgery

re
 Compliance with post-operative nasal retainers is suboptimal
 Retainer design requires investigation to improve tolerance and thus compliance

Authors affiliations er
Vinciane Pouleta, Zoé Cavalliera, Frédéric Vaysseb, Frédéric Lauwersa, Alice Prevosta
pe
a Maxillo-Facial Surgery Department, Toulouse Purpan University Hospital, Place Baylac, 31059,
Toulouse, France ([email protected]; [email protected])
b Odontology Department, Toulouse Purpan University Hospital, 3 chemin des Maraîchers, 31400

Toulouse, France ([email protected])

As corresponding author, I confirm that this work has not been published before and is currently not
ot

under consideration for publication elsewhere. None of the authors have any conflicts of interest to
declare that are relevant to the article contents, and all authors comply to the latest authorship
criteria from the International Committee of Medical Journal Editors.
tn

Please do not hesitate to contact me if you have any questions.

Yours faithfully,
rin
ep
Pr

Dr Vinciane Poulet (corresponding author)

This preprint research paper has not been peer reviewed. Electronic copy available at: https://ssrn.com/abstract=4675780
 The use of nasal retainers in primary management of cleft lip : current practices
in France

ed
Abstract
Background: The primary surgical management of cleft lip (CL) or cleft lip and palate
(CLP) aims to achieve harmonious lip and nasal symmetry while ensuring satisfactory

iew
ventilation. Postoperative nasal retainers are commonly employed, but their efficacy is
debated. This study therefore explored primary cheilorhinoplasty practices in France
and nasal retainer use.

Methods: A survey was distributed among surgeons within and outside the French
National Reference Center for Clefts and Facial Malformations (MAFACE) network.

v
Questions focused on age when primary cleft closure is performed, retainer types
used, duration of conformation, and estimated patient compliance. Data was collected

re
from March to July 2023.

Results: Thirty-two surgeons responded with substantial variations in practices. For

isolated CL, the age at primary cleft closure ranged from 1–6 months, with 28%
performing surgery at 3 months, 12.5% between 3–6 months, 44% at 6 months. In
er
cases with CLP, 63% performed simultaneous surgery at 6 months. Two surgeons
(6%) reported preoperative nasoalveolar molding and 30 surgeons (94%) reported
postoperative nasal retainer usage. The type of retainer used immediately after surgery
varied, with equal use of commercial retainers (31%), silicone sheets (31%), and in-
pe
house retainers (31%). Duration of retainer prescription was in majority 3–4 months.
Notably, 44% of surgeons reported adherence rates falling <70% for the recommended
conformation duration, while 25% reported very good compliance.

Conclusion: There is significant diversity in primary cheilorhinoplasty and nasal

ot

conformation practices in France. Suboptimal patient compliance demonstrates the

need for improved retainer design and strategies to enhance compliance.

Keywords
tn

Cleft lip, Nasal conformation, Nasal retainer, Cleft lip closure, Primary cheilorhinoplasty

Abbreviations
CL: cleft lip, CLP: cleft lip and palate
rin

Funding
This research did not receive any specific funding from the public, commercial, or not-
for-profit sectors.
ep

Declarations of Interest: None

1. Introduction
Pr

Primary surgical management of patients with cleft lip (CL) or cleft lip and palate (CLP)
aims to achieve harmony and symmetry between the lip and nose, while ensuring
satisfactory ventilation to promote normal facial growth. Numerous studies have strived

This preprint research paper has not been peer reviewed. Electronic copy available at: https://ssrn.com/abstract=4675780
 to characterize and quantify residual nasal deformity and asymmetry following primary
cheilorhinoplasty [1-6] and to understand the underlying mechanisms [7,8].

ed
The use of nasal retainers is common practice after surgery. Various types of nasal
retainers are used worldwide, but they generally consist of two flexible stents placed
in the nasal vestibule, connected by a columellar bridge [9]. The retainers are worn
continuously for a few postoperative months with the objectives of maintaining the
desired shape and symmetry of the nostrils and septum during the healing process, as

iew
well as restoring normal ventilation. Additionally, these retainers help prevent the
formation of hematic collections and subsequent fibrous scars. While the scientific
evidence for the benefit of postoperative nasal conformers remains debated [10], due
to the challenges in measuring the long-term effects, most surgeons believe they play
a crucial role in achieving optimal outcomes [11,12]. Finally, despite generally good
patient tolerance and adherence [9], challenges may arise in ensuring patient

v
compliance with wearing the retainer as recommended and prescribed by the surgeon.

re
To date, practices are heterogeneous regarding the primary surgical management of
children with CL and CLP, including the concept of postoperative nasal conformation
[1,5,9]. The aim of this study was thus to establish an inventory of current practices in
the management of patients with CL and CLP in France, as well as to evaluate the
experiences and opinions of various specialized practitioners regarding postoperative
er
nasal conformation. To do this, we conducted a national French survey among
surgeons to assess primary cheilorhinoplasty practices in France.

2. Material and methods

pe
2.1 The survey

The survey was distributed in French directly by email to all surgeons in France
performing primary cheilorhinoplasty within the French National Reference Center for
ot

Clefts and Facial Malformations network (MAFACE network; Centre de Référence

Maladies Rares et Centre Expert Fentes et Malformations Faciales). This network
includes 24 centers (public and private centers). The survey was also sent to some
surgeons not within the MAFACE network. Surgeons were able to complete the survey
tn

between March and July 2023. The questions were as follows (English translation):

1. At what age do your patients typically undergo primary cheilorhinoplasty for

isolated cleft lip or labio-alveolar cleft? (age in months)
2. At what age do your patients typically undergo primary cheilorhinoplasty for cleft
rin

lip with associated velar or velo-palatal cleft?

3. On average, how many primary cheilorhinoplasty surgeries are performed at
your center annually?
4. Do you employ preoperative molding?
ep

5. Do you use nasal retainers following primary cheilorhinoplasty?

6. Which type of splints do you employ immediately after surgery?
- Flexible silicone splints (placed in each nostril, accompanied by a silicone sheet
on the nasal tip)
- Commercial conformers (Sebbin®, Bone3D®, etc.)
Pr

- Home-made conformers
- Other

This preprint research paper has not been peer reviewed. Electronic copy available at: https://ssrn.com/abstract=4675780
 7. During the immediate postoperative period, from D0 until suture removal (D7-
15), are the splints:

ed
- Fixed (sutured)
- Removable
8. If you employ fixed splints after suture removal, for how long do you leave them
in place?
9. If you employ commercially available splints, which brand do you use?

iew
10. Does the design of the splints used during the first postoperative month differ
from those worn after? If so, please specify the splints used at each stage.
11. Typically, how long do you prescribe the use of nasal splints after primary
cheilorhinoplasty?
12. In your experience, how would you rate patient compliance with wearing the
prescribed splints following primary cheilorhinoplasty?

v
- Very good (90-100% adherence to prescribed duration)
- Good (70–89%)

re
- Moderate (50–69%)
- Poor (0–49%)
13. In your opinion, what aspects of current splints need improving?

2.2 Data collection and analysis

er
Information regarding surgeon identity and practice center were also collected, but all
identities have been anonymized for publication. Ethical approval was waived by
Toulouse University Hospital given the non-interventional nature of the study according
pe
to French Jardé law. We performed a descriptive analysis of survey results, with
categorical variables expressed as frequencies and percentages.

3. Results
ot

A total of 32 surgeons answered the survey practicing in 26 different centers

throughout France. Among their responses, we identified 30 different protocols for CL
and CLP management. Below we have summarized the results for each
tn

corresponding survey question:

1. When CL is not associated with cleft palate: the majority of surgeons (n=14/32;
44%) reported performing primary cheilorhinoplasty at the age of 6 months,
rin

followed by n=9/32 (28%) at the age of 3 months, n=4/32 (12.5%) between 3–6
months, n=4/32 (12.5%) at 1 month, and n=1/32 (3%) at 2 months (Fig.1).

12.5%
1
ep

3%
2
44% 3
28%
3 to 6
Pr

6
12.5%
Fig. 1. Age (in months) when primary cheilorhinoplasty is performed when CL
is not associated with cleft palate

This preprint research paper has not been peer reviewed. Electronic copy available at: https://ssrn.com/abstract=4675780
 2. When CL is associated with cleft palate: the majority of surgeons (n=20/32;

ed
63%) reported performing concomitant cheilorhinoplasty and veloplasty at the
age of 6 months (Fig.2). The age then varied for the remaining surgeons
(n=12/32; 37%). Among these surgeons, note that n=2/32 (6%) specifically
reported delaying surgery from the usual 3 months or 3–6 months to 6 months,
and n=1/32 (3%) surgeon reported specifically performing surgery earlier at 3

iew
months instead of at 3–6 months.

3% 1
12%
2

v
16% 3
63% 3 to 6
6%

re
6

Fig. 2. Age (in months) when primary cheilorhinoplasty is performed when CL is

associated with cleft palate er
3. Annual number of primary cheilorhinoplasty surgeries performed per affiliated
center were 10–19 for n=16/32 (50%) surgeons and ≥20 for n=16/32 (50%)
surgeons (Fig.3).
pe
10
Number of surgeons

8
6
4
ot

2
0
10-1415-1920-2425-2930-3435-39 40+
tn

Number of surgeries

Fig.3. Number of primary cheilorhinoplasty surgeries performed per year by the centers
rin

of the practicing surgeons.

4. Two (n=2/32; 6%) surgeons, practicing in the same center, reported using
nasoalveolar molding before surgery versus n=30/32 (94%) surgeons not using
ep

nasoalveolar molding before surgery.

5. A total of n=30/32 (94%) surgeons reported the postoperative use of nasal

retainers versus n=2/32 (6%) surgeons almost never using nasal retainers after
surgery. Among the latter two surgeons, n=1/32 (3%) reported a general bad
Pr

experience in the postoperative use of nasal retainers and the other (n=1/32;
3%) a lack of need for splints if suspension sutures are used. These surgeons
stated using commercial retainers for the rare cases when they do use retainers.

This preprint research paper has not been peer reviewed. Electronic copy available at: https://ssrn.com/abstract=4675780
 Note that the two aforementioned surgeons using nasoalveolar molding before
surgery reported using retainers after surgery.

ed
6. Immediately after surgery, n=10/32 (31%) surgeons report using commercial
retainers, n=10/32 (31%) silicone sheets, and n=10/32 (31%) ″in-house″
retainers (Fig.4).

iew
2
6%
10 Silicone sheets

v
32%
10
31% Inhouse retainer

re
Commercial retainers

10
31% No retainer
er
Fig. 4. Immediate postoperative nasal retainer type used

7. The splints used immediately after surgery were reported in majority as fixed for
pe
n=28/32 (87.5%) surgeons and removable for n=4/32 (12.5%) surgeons.

8. A total of n=5/32 (16%) surgeons reported using sutured retainers after D7

(suture removal).

9. In terms of commercially-available retainers, n=8/32 (25%) surgeons declared

ot

using Sebbin® retainers, n=5/32 (16%) Bone3D® retainers, n=1/32 (3%) Koken®
retainers, and n=1/32 (3%) Nosefit® retainers.
tn

10. After the first postoperative month, n=5/23 (22%) surgeons reported using
different kinds of splints for the conformation period. Among these, four
surgeons declare changing the type of retainer for switching to anatomical
splints (Bone 3D® or in-house).
rin

11. The nasal splints were prescribed for up to between 1.5–6 months after surgery,
with the majority of surgeons prescribing for 3 (n=12/32; 38% surgeons) or 4
(n=15/32; 47%) months for conformation (Fig.5).
ep

9% 3% 3%

1.5
2
38%
47% 3
Pr

4
6

Fig. 5. Duration of conformation (in months)

This preprint research paper has not been peer reviewed. Electronic copy available at: https://ssrn.com/abstract=4675780
 12. Overall compliance to prescription of nasal retainer wearing was estimated as

ed
poor for n=3/32 (9.4%) surgeons, moderate for n=11/32 (34.4%) surgeons,
good for n=10/32 (31.2%) surgeons, and very good for n=8/32 (25%) surgeons
(Fig.6).

iew
12
Number of surgeons

10
8
6
4
2

v
0
0-49% 50-69% 70-89% 90-100%

re
% Estimated compliance

Fig. 6. Estimated compliance

13. The following characteristics of the splints require improving according to the
surgeons (in order of most frequent first):
er
- The retentive and stable nature of the retainer: n=23/32 (72%) surgeons
pe
- The range of sizes available: n=17/32 (53%) surgeons
- Endonasal design: n=14/32 (44%) surgeons
- Ease of insertion and use by parents: n=11/32 (34%) surgeons
- The number of available designs (e.g. for right or left side, unilateral or bilateral
clefts): n=10/32 (31%) surgeons
- Exonasal columellar design: n=9/32 (28%) surgeons
ot

- Exonasal lip design: n=7/32 (22%) surgeons

- Exonasal alas design: n=6/32 (19%) surgeons
- Increased flexibility (i.e. the splints are too stiff): n=4/32 (13%) surgeons
tn

- Increased stiffness (i.e. the splints are too flexible): n=3/32 (9%) surgeons
- None: n=2/32 (6%) surgeons
- The color: n=1/32 (3%) surgeon
rin

4. Discussion

Both the primary surgical management of children with CL and CLP as well as the
practices for postoperative nasal conformation remain diverse [1,5,9]. Therefore, a
ep

national French survey was conducted in this study among surgeons to assess primary
cheilorhinoplasty practices. Overall, the findings highlight substantial variation in
practices among different centers in France regarding the age at which primary
cheilorhinoplasty is performed, the choice of nasal retainer, and the duration of
Pr

postoperative conformation.

To begin, our study had a high response rate, with participating surgeons completing
the survey from all regions of France. Therefore, we consider the responses reliable

This preprint research paper has not been peer reviewed. Electronic copy available at: https://ssrn.com/abstract=4675780
 given they are representative of the surgeons involved in cleft lip management
throughout France. Moreover, despite the ongoing debate in the literature [10], the

ed
efficacy of postoperative nasal retainers still appears to be acknowledged by the
majority of survey participants in this study [11,12]. Indeed, n=30/32 (94%) of surgeons
reported their routine postoperative use of nasal retainers. Conversely, preoperative
nasoalveolar molding is a rarely adopted practice in France (n=2/32 (6%) surgeons
here) despite being more frequently employed in other countries [13-15].

iew
It is noteworthy that a considerable proportion of surgeons (44%) participating in the
survey expressed their concerns about the adequacy of their postoperative nasal
conformation prescription, with estimated adherence rates below 70% compared to
their prescribed regimen. Furthermore, 75% of the surveyed surgeons believe that the
retentive and stable aspect of the retainer should be improved; i.e. The lack of stability

v
of the conformers is a major cause of non-compliance with the prescription. Indeed,
some surgeons mentioned how parents express fear about their child potentially

re
swallowing the conformer or find it uncomfortable when putting back in place (data not
shown). This emphasizes the need for further research on nasal retainers and
strategies to enhance compliance given suboptimal adherence may impact the overall
long-term treatment efficacy.
er
The use of anthropometry in ergonomics and product design is well-established [16].
A better understanding of nasal shape in non-cleft children during the conformation
period may help us to design a new type of nasal retainer with better tolerance.
According to the survey results, this period ranges from 1 month to 1 year, with some
pe
surgeons performing the procedure as early as 1 month and others waiting until 6
months of age, with a maximum proposed duration of conformation of 6 months.
Although some studies have examined the three-dimensional nasal shape in this age
group [17, 18], they feature limited patient involvement. Furthermore, this age group
does not coincide with the time when cartilage is expected to be most malleable. During
ot

the neonatal period (up to six weeks), higher maternal estrogen levels promote the
ability of cartilage to respond to deformation. This enhanced responsiveness is
attributed to the increased production of hyaluronic acid, which is responsible for the
pliable nature of neonatal cartilage [19].
tn

The primary limitation of our investigation stems from our chosen methodology which
relied on an online questionnaire. While we received responses from nearly all expert
centers within the MAFACE Network, as well as input from some practitioners outside
this network, it is inevitable that some surgeons in France were unaware of our survey
rin

or did not participate.

Overall, it is vital to conduct additional investigations to precisely explore the nasal

shape of non-cleft children during the relevant conformation period. These studies
ep

would provide valuable insights into developments of nasal conformers according to

patient age and sex. After, we would be able to draw conclusions on the potential
benefits and optimal duration of nasal conformation, and on the age at which
conformation proves most effective. More precise recommendations could then be put
forward for the surgical and postoperative management of children with CL and CLP,
Pr

in turn improving compliance of retainer use and thus resulting in better long-term
outcomes.

This preprint research paper has not been peer reviewed. Electronic copy available at: https://ssrn.com/abstract=4675780
 5. Acknowledgements

ed
We thank Jacqueline Butterworth (Toulouse University Hospital) for help with
manuscript drafting, Pr Pascal Swider (Institut Mécanique des Fluides de Toulouse),
and all the surgeons who took the time to answer the survey.

iew
6. References

[1] Becker M, Svensson H, Jacobsson S. Clinical examination compared with

morphometry of digital photographs for evaluation of repaired cleft lips. Scand J Plast
Reconstr Surg Hand Surg 1998; 32, 301–306.
https://doi.org/10.1080/02844319850158642

v
[2] Beidas OE, Thompson DM, El Amm CA. Anthropometric Effect of Mucoperiosteal

re
Nostril Floor Reconstruction in Complete Cleft Lip. J Craniofac Surg 2016; 27, 19–26.
https://doi.org/ 10.1097/SCS.0000000000002169

[3] Bugaighis I, Mattic C, Tiddeman B, Hobson R. 3D asymmetry of operated children

with oral clefts. Orthod Craniofac
er Res 2014; 17, 27–37.
https://doi.org/10.1111/ocr.12026

[4] Feijo MJ, Brandão SR, Pereira RM, Santos MB, Justino da Silva H. Nostril
Morphometry Evaluation before and after Cleft Lip Surgical Correction: Clinical
pe
Evidence. Int Arch Otorhinolaryngol 2014; 18, 192–197. https://doi.org/10.1055/s-
0033-1352506

[5] Pietruski P, Majak M, Pawlowska E, Skiba A, Antoszewski B. A novel computer

system for the evaluation of nasolabial morphology, symmetry, and aesthetics after
ot

cleft lip and palate treatment. Part 2: Comparative anthropometric analysis of patients
with repaired unilateral complete cleft lip and palate and healthy individuals. J
Craniomaxillofac Surg 2017; 45, 505–514. https://doi.org/10.1016/j.jcms.2017.01.022
tn

[6] Denadai R, Chou PY, Seo HJ, Lonic D, Lin HH et al. Patient- and 3D morphometry-
based nose outcomes after skeletofacial reconstruction. Sci Rep 2020; 10, 4246.
https://doi.org/10.1038/s41598-020-61233-6

[7] Huang H, Luo X, Cheng X, Zhang Z, Ma G et al. Recapitulation of Unilateral Cleft

rin

Lip Nasal Deformity on Normal Nasal Structure: A Finite Element Model Analysis. J
Craniofac Surg 2018; 29, 2220–2225.
https://doi.org/10.1097/SCS.0000000000005024
ep

[8] Huang H, Luo X, Cheng X, Shi B, Li J. Biomechanical simulation of correcting

primary unilateral cleft lip nasal deformity. PLoS One 2018; 13, e0199964.
https://doi.org/10.1371/journal.pone.0199964

[9] Hennocq Q, Person H, Hachani M, Bertin H, Corre P, et al. Quality of life and nasal
Pr

splints after primary cleft lip and nose repair: Prospective assessment of information
and tolerance. J Craniomaxillofac Surg 2018; 46, 1783–1789.
https://doi.org/10.1016/j.jcms.2018.07.022

This preprint research paper has not been peer reviewed. Electronic copy available at: https://ssrn.com/abstract=4675780
 [10] Rossell-Perry P, Romero-Narvaez C, Gavino-Gutierrez A, Figallo-Hudtwalcker O.

ed
Postoperative Nasal Conformers in Cleft Rhinoplasty: Are They Efficacious? J
Craniofac Surg. 2023 Jul-Aug 01;34(5):1416-1419.
https://doi.org/10.1097/SCS.0000000000009213.

[11] Funayama E, Yamamoto Y, Oyama A, Furukawa H, Murao N et al. Comparison

iew
of Nasal Symmetry Between Presurgical Nasal Stenting and Postsurgical Nasal
Retainer Placement in Unilateral Clefts. J Craniofac Surg 2019; 30, 133–136.
https://doi.org/10.1097/SCS.0000000000004959

[12] Yeow VK, Chen PK, Chen YR, Noordhoff SM. The use of nasal splints in the
primary management of unilateral cleft nasal deformity. Plast Reconstr Surg 1999; 103,

v
1347–1354. https://doi.org/10.1097/00006534-199904050-00002

re
[13] Bous RM, Kochenour N, Valiathan M. A novel method for fabricating nasoalveolar
molding appliances for infants with cleft lip and palate using 3-dimensional workflow
and clear aligners. Am J Orthod Dentofacial Orthop. 2020 Sep;158(3):452-458.
https://doi.org/10.1016/j.ajodo.2020.02.007
er
[14] Abd El-Ghafour M, Aboulhassan MA, Fayed MMS, El-Beialy AR, Eid FHK, Hegab
SE, El-Gendi M, Emara D. Effectiveness of a Novel 3D-Printed Nasoalveolar Molding
Appliance (D-NAM) on Improving the Maxillary Arch Dimensions in Unilateral Cleft Lip
and Palate Infants: A Randomized Controlled Trial. Cleft Palate Craniofac J. 2020
pe
Dec;57(12):1370-1381. https://doi.org/ 10.1177/1055665620954321.

[15] Nazarian Mobin SS, Karatsonyi A, Vidar EN, Gamer S, Groper J, Hammoudeh JA,
Urata MM. Is presurgical nasoalveolar molding therapy more effective in unilateral or
bilateral cleft lip-cleft palate patients? Plast Reconstr Surg. 2011 Mar;127(3):1263-
ot

1269. doi: 10.1097/PRS.0b013e318205f3ac

[16] Dianat I, Molenbroek J, Castellucci H. A review of the methodology and

applications of anthropometry in ergonomics and product design. Ergonomics 2018;
tn

61, 1696–1720. https://doi.org/ 10.1080/00140139.2018.1502817

[17]Brons S, Meulstee JW, Nada RM, Kuijpers MAR, Bronkhorst EM et al. Uniform 3D
meshes to establish normative facial averages of healthy infants during the first year
of life. PLoS One 2019; 14, e0217267. https://doi.org/10.1371/journal.pone.0217267
rin

[18]Jahanbin A, Emami A, Eslami N. Anthropometric Parameters of Nasomaxillary

Complex in 2, 4, 6, and 12-Month-Old Children as a Reference for Cleft Lip and Palate
Reconstructive Surgery. J Craniofac Surg 2021; 32, 597–599.
ep

https://doi.org/10.1097/SCS.0000000000006830

[19] Byrd HS, Langevin CJ, Ghidoni LA. Ear molding in newborn infants with auricular
deformities. Plast Reconstr Surg. 2010 Oct;126(4):1191-1200.
https://doi.org/10.1097/PRS.0b013e3181e617bb
Pr

This preprint research paper has not been peer reviewed. Electronic copy available at: https://ssrn.com/abstract=4675780